Safe abortion: technical and policy guidance for health systems. Second edition

Transcription

1 Safe abortion: technical and policy guidance for health systems Second edition

2

3 Safe abortion: technical and policy guidance for health systems Second edition

4 Acknowledgements WHO is grateful for the technical contributions of the external experts who participated in the initial online consultation, the technical consultation and the review of this guideline. (Details of participants and additional external reviewers are provided in Annex 4.) Funding source The development of these guidelines was supported by the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP). WHO Library Cataloguing-in-Publication Data Safe abortion: technical and policy guidance for health systems 2 nd ed. 1.Abortion, Induced - methods 2.Abortion, Induced - standards. 3.Prenatal care - organization and administration 4.Prenatal care - standards 5.Maternal welfare 6.Health policy 7.Guidelines. I.World Health Organization. ISBN (NLM classification: WQ 440) World Health Organization All rights reserved. Publications of the World Health Organization are available on the WHO web site ( or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: ; fax: ; bookorders@who.int). Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press through the WHO web site ( The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed in ii Safe abortion: technical and policy guidance for health systems

5 Abbreviations D&C dilatation and (sharp) curettage D&E EVA GMP dilatation and evacuation electric vacuum aspiration good manufacturing practice GRADE Grading of Recommendations Assessment, Development and Evaluation hcg HIV HLD ICPD IUD IV KCl LMP MVA NGO PG Rh RTI STI UN human chorionic gonadotrophin human immunodeficiency virus high-level disinfection International Conference on Population and Development intrauterine device intravenous potassium chloride last menstrual period manual vacuum aspiration nongovernmental organization prostaglandin Rhesus (blood group) reproductive tract infection sexually transmitted infection United Nations UNFPA United Nations Population Fund UNPD USA WHO United Nations Population Division United States of America World Health Organization Safe abortion: technical and policy guidance for health systems iii

6 Definitions used in this document y Duration or gestational age of pregnancy (gestation): the number of days or weeks since the first day of the woman s last normal menstrual period (LMP) in women with regular cycles (for women with irregular cycles, the gestational age may need to be determined by physical or ultrasound examination). The first trimester is generally considered to consist of the first 12 or the first 14 weeks of pregnancy (see Table 1). Table 1. Equivalent gestational ages in weeks and days during the first trimester Weeks of gestation Days of gestation < Adapted from: International statistical classification of diseases and health related problems, 10th revision ICD-10, Vol. 2, 2008 Edition. Geneva, World Health Organization, y Medical methods of abortion (medical abortion): use of pharmacological drugs to terminate pregnancy. Sometimes the terms non-surgical abortion or medication abortion are also used. y Menstrual regulation: uterine evacuation without laboratory or ultrasound confirmation of pregnancy for women who report recent delayed menses. y Osmotic dilators: short, thin rods made of seaweed (laminaria) or synthetic material. After placement in the cervical os, the dilators absorb moisture and expand, gradually dilating the cervix. y Routes of misoprostol administration: oral pills are swallowed immediately; buccal pills are placed between the cheek and gums and swallowed after 30 minutes; sublingual pills are placed under the tongue and swallowed after 30 minutes; vaginal pills are placed in the vaginal fornices (deepest portions of the vagina) and the woman is instructed to lie down for 30 minutes. y Surgical methods of abortion (surgical abortion): use of transcervical procedures for terminating pregnancy, including vacuum aspiration and dilatation and evacuation (D&E). (See Chapter 2, Section for a more detailed description of methods of surgical abortion.) Human Rights terminology y International human rights treaty: also sometimes called a Covenant or a Convention, is adopted by the international community of States, normally at the United Nations General Assembly. Each treaty sets out a range of human rights, and corresponding obligations which are legally binding on States that have ratified the treaty. Annex 7 includes a list of these treaties. iv Safe abortion: technical and policy guidance for health systems

7 y Treaty monitoring body: each of the international human rights treaties is monitored by a designated treaty monitoring body (see Annex 7). The treaty monitoring bodies are committees composed of independent experts. Their main function is to monitor the States compliance with the treaty in question, including through the examination of State reports. y General comments/recommendations: a treaty monitoring body s interpretation of the content of human rights provisions on thematic issues or its methods of work. General comments seek to clarify the reporting duties of State parties with respect to certain provisions and suggest approaches to implementing treaty provisions. y Concluding observations: following submission of a State report and a constructive dialogue with the State party to the particular convention, treaty monitoring bodies issue concluding observations to the reporting State, which are compiled in an annual report and sent to the United Nations General Assembly. y Regional human rights treaties: States adopted human rights treaties in Africa, the Americas, Europe and the Middle East. Regional human rights bodies, such as the African Union, the Organization of American States, the Council of Europe, the European Union, and the League of Arab States monitor States compliance with the treaties. To date, there are no regional human rights treaties in South-East Asia or the Western Pacific. Annex 7 includes a list of regional human rights treaties. y Human rights standards: the meaning and scope of human rights as interpreted and applied by the human rights bodies tasked with this work, e.g. international, regional and national courts, and human rights committees. Safe abortion: technical and policy guidance for health systems v

8 vi Safe abortion: technical and policy guidance for health systems

9 CONTENTS Executive summary 1 Process of guideline development 10 Background 10 Methods 10 Decision-making during the technical consultation 12 Document preparation and peer review 12 Dissemination of the guidance document 12 Updating the guidelines 13 Chapter 1 16 Safe abortion care: the public health and human rights rationale Background Public health and human rights Pregnancies and abortions Health consequences of unsafe abortion Contraceptive use, accidental pregnancies and unmet need for family planning Regulatory and policy context Economic costs of unsafe abortion 26 Chapter 2 30 Clinical care for women undergoing abortion Pre-abortion care Methods of abortion Post-abortion care and follow-up 52 Chapter 3 62 Planning and managing safe abortion care Introduction Constellation of services Evidence-based standards and guidelines Equipping facilities and training health-care providers Monitoring, evaluation and quality improvement Financing The process of planning and managing safe abortion care 80 Safe abortion: technical and policy guidance for health systems vii

10 Chapter 4 86 Legal and policy considerations Women s health and human rights Laws and their implementation within the context of human rights Creating an enabling environment 98 Annex 1 Research gaps identified at the technical consultation 105 Annex 2 Final GRADE questions and outcomes 106 Annex 3 Standard GRADE criteria for grading of evidence 109 Annex 4 Participants in the technical consultation 110 Annex 5 Recommendations from the technical consultation for the second edition of Safe abortion: technical and policy guidance for health systems 113 Annex 6 Post-abortion medical eligibility for contraceptive use 120 Annex 7 Core international and regional human rights treaties 122 viii Safe abortion: technical and policy guidance for health systems

11 Executive summary Over the past two decades, the health evidence, technologies and human rights rationale for providing safe, comprehensive abortion care have evolved greatly. Despite these advances, an estimated 22 million abortions continue to be performed unsafely each year, resulting in the death of an estimated women and disabilities for an additional 5 million women (1). Almost every one of these deaths and disabilities could have been prevented through sexuality education, family planning, and the provision of safe, legal induced abortion and care for complications of abortion. In nearly all developed countries, safe abortions are legally available upon request or under broad social and economic grounds, and services are generally easily accessible and available. In countries where induced abortion is legally highly restricted and/or unavailable, safe abortion has frequently become the privilege of the rich, while poor women have little choice but to resort to unsafe providers, causing deaths and morbidities that become the social and financial responsibility of the public health system. In view of the need for evidence-based best practices for providing safe abortion care in order to protect the health of women, the World Health Organization (WHO) has updated its 2003 publication Safe abortion: technical and policy guidance for health systems (2). In this process, the WHO standards for guideline development have been followed, including: identification of priority questions and outcomes; retrieval, assessment and synthesis of evidence; formulation of recommendations; and planning for dissemination, implementation, impact evaluation and updating. For the clinical recommendations presented in Chapter 2, evidence profiles related to the prioritized questions were prepared, based upon recent systematic reviews, most of which are included in the Cochrane Database of Systematic Reviews. In addition, Chapters 1, 3 and 4 of the original 2003 publication were reviewed and updated to reflect the latest estimates on unsafe abortion worldwide, new literature on the topic of service delivery, and new developments in international, regional and national human rights law. A guideline development group, comprising members of an international panel of experts, reviewed and revised the draft recommendations based on the evidence profiles, through a participatory, consensus-driven process. The target audience for this guidance is policy-makers, programme managers and providers of abortion care. The use of the clinical recommendations should be individualized to each woman, with emphasis on Safe abortion: technical and policy guidance for health systems 1

12 her clinical status and the specific method of abortion to be used, while considering each woman s preferences for care. While legal, regulatory, policy and service-delivery contexts may vary from country to country, the recommendations and best practices described in this document aim to enable evidence-based decision-making with respect to safe abortion care. Details of their development and application of the quality of evidence grading are found under the Methods section, page 10. Box 1 presents the recommendations related to specific methods of surgical abortion, while Box 2 summarizes the recommendations for medical abortion. Box 3 addresses recommendations for the surgical or medical methods preferred beyond 12 weeks of gestation. Box 4 summarizes the recommendations related to clinical care prior to induced abortion, including consideration of cervical preparation, use of diagnostic ultrasonography, use of antibiotics and pain-management options. Box 5 summarizes the recommendations related to post-abortion care, including initiation of contraception, treatment of incomplete abortion and whether there is a medical need for routine followup visits after induced abortion. Box 6 summarizes the main recommendations from Chapter 3 related to application of the clinical guidance in establishing and strengthening abortion services, including development of national standards and guidelines; training and equipping of service providers; assessing, prioritizing and financing of health-system needs; introducing and scaling-up of interventions; and monitoring and evaluation. Finally, Box 7 summarizes the main recommendations from Chapter 4 concerning legal, policy and human rights dimensions. Members of the guideline development group noted important knowledge gaps that need to be addressed through primary research. Overall, the group placed a high value on research to demedicalize abortion care. Observations regarding the need for future research are presented in Annex 1. BOX 1 Recommended methods for surgical abortion Vacuum aspiration is the recommended technique of surgical abortion for pregnancies of up to 12 to 14 weeks of gestation. The procedure should not be routinely completed by sharp curettage. Dilatation and sharp curettage (D&C), if still practised, should be replaced by vacuum aspiration. (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: low to moderate.) See also: Annex 5, Recommendation 1, page Safe abortion: technical and policy guidance for health systems

13 BOX 2 Recommended methods for medical abortion The recommended method for medical abortion is mifepristone followed by misoprostol. For pregnancies of gestational age up to 9 weeks (63 days) The recommended method for medical abortion is mifepristone followed 1 to 2 days later by misoprostol. [See notes below for dosages, and routes of administration.] (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: moderate.) Dosages and routes of administration for mifepristone followed by misoprostol Mifepristone should always be administered orally. The recommended dose is 200 mg. Administration of misoprostol is recommended 1 to 2 days (24 to 48 hours) following ingestion of mifepristone. y For vaginal, buccal or sublingual routes, the recommended dose of misoprostol is 800 μg. y For oral administration, the recommended dose of misoprostol is 400 μg. y With gestations up to 7 weeks (49 days) misoprostol may be administered by vaginal, buccal, sublingual or oral routes. After 7 weeks of gestation, oral administration of misoprostol should not be used. y With gestations up to 9 weeks (63 days) misoprostol can be administered by vaginal, buccal or sublingual routes. See also: Annex 5, Recommendation 2, page 113. For pregnancies of gestational age between 9 and 12 weeks (63 84 days) The recommended method for medical abortion is 200 mg mifepristone administered orally followed 36 to 48 hours later by 800 μg misoprostol administered vaginally. Subsequent misoprostol doses should be 400 μg, administered either vaginally or sublingually, every 3 hours up to four further doses, until expulsion of the products of conception. (Strength of recommendation: weak. Quality of evidence based on one randomized controlled trial and one observational study: low.) See also: Annex 5, Recommendation 3, page 114. For pregnancies of gestational age over 12 weeks (84 days) The recommended method for medical abortion is 200 mg mifepristone administered orally followed 36 to 48 hours later by repeated doses of misoprostol. [See notes below for dosages, and routes of administration of misoprostol.] (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: low to moderate.) y With gestations between 12 and 24 weeks, the initial misoprostol dose following oral mifepristone administration may be either 800 μg administered vaginally or 400 μg administered orally. Subsequent misoprostol doses should be 400 μg, administered either vaginally or sublingually, every 3 hours up to four further doses. y For pregnancies beyond 24 weeks, the dose of misoprostol should be reduced, due to the greater sensitivity of the uterus to prostaglandins, but the lack of clinical studies precludes specific dosing recommendations. See also: Annex 5, Recommendation 6, page 115. Safe abortion: technical and policy guidance for health systems 3

14 box 2 continued Recommended methods for medical abortion Where mifepristone is not available For pregnancies of gestational age up to 12 weeks (84 days) The recommended method of medical abortion is 800 μg of misoprostol administered by vaginal or sublingual routes. Up to three repeat doses of 800 μg can be administered at intervals of at least 3 hours, but for no longer than 12 hours. (Strength of recommendation: strong. Quality of evidence based on one randomized controlled trial: high.) See also: Annex 5, Recommendation 4, page 115. For pregnancies of gestational age over 12 weeks (84 days) The recommended method of medical abortion is 400 μg of misoprostol administered vaginally or sublingually, repeated every 3 hours for up to five doses. (Strength of recommendation: strong. Quality of evidence based on one randomized controlled trial: low to moderate.) y For pregnancies beyond 24 weeks, the dose of misoprostol should be reduced, due to the greater sensitivity of the uterus to prostaglandins, but the lack of clinical studies precludes specific dosing recommendations. See also: Annex 5, Recommendation 6, pages 115 and 116. BOX 3 Recommended methods of abortion for pregnancies of gestational age over 12 to 14 weeks Dilatation and evacuation (D&E) and medical methods (mifepristone and misoprostol; misoprostol alone) are both recommended methods for abortion for gestation over 12 to 14 weeks. Facilities should offer at least one, and preferably both methods, if possible, depending on provider experience and the availability of training. (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: low.) See also: Annex 5, Recommendation 5 page Safe abortion: technical and policy guidance for health systems

15 BOX 4 Recommendations for care preceding induced abortion Cervical preparation Prior to surgical abortion, cervical preparation is recommended for all women with a pregnancy over 12 to 14 weeks of gestation. Its use may be considered for women with a pregnancy of any gestational age. (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: low.) y Any one of these methods of cervical preparation before surgical abortion in the first trimester is recommended: oral mifepristone 200 mg (24 to 48 hours in advance); or misoprostol 400 μg administered sublingually, 2 to 3 hours prior to the procedure; or misoprostol 400 μg administered vaginally 3 hours prior to the procedure; or laminaria placed intracervically 6 to 24 hours prior to the procedure. See also: Annex 5, Recommendation 7, page 116. (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: low to moderate.) All women undergoing dilatation and evacuation (D&E) with a pregnancy over 14 weeks of gestation should receive cervical preparation prior to the procedure. (Strength of recommendation: strong. Quality of the evidence based on randomized controlled trials: low to moderate.) y The recommended methods of cervical preparation prior to dilatation and evacuation (D&E) after 14 weeks of gestation are osmotic dilators or misoprostol. (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: moderate.) See also: Annex 5, Recommendation 8, page 117. Safe abortion: technical and policy guidance for health systems 5

16 box 4 continued Recommendations for care preceding induced abortion Ultrasound scanning Use of routine pre-abortion ultrasound scanning is not necessary. (Strength of recommendation: strong. Quality of evidence based on a randomized controlled trial and observational studies: very low.) See also: Annex 5, Recommendation 12, page 118. Prophylactic antibiotics All women having surgical abortion, regardless of their risk of pelvic inflammatory infection, should receive appropriate prophylactic antibiotics pre- or peri-operatively. (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: moderate.) See also: Annex 5, Recommendation 11, page 118. For women having medical abortion, routine use of prophylactic antibiotics is not recommended. See also: Annex 5, Recommendation 11, page 118. Pain management (Strength of recommendation: strong. Quality of evidence based on one observational trial: very low.) All women should be routinely offered pain medication (e.g. non-steroidal anti-inflammatory drugs) during both medical and surgical abortions. General anaesthesia is not recommended routinely for vacuum aspiration abortion or dilatation and evacuation (D&E). (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: low.) Remarks: Medication for pain management for both medical and surgical abortions should always be offered, and provided without delay to women who desire it. In most cases, analgesics, local anaesthesia and/or conscious sedation supplemented by verbal reassurance are sufficient, although the need for pain management increases with gestational age. See also: Annex 5, Recommendation 14, page Safe abortion: technical and policy guidance for health systems

17 BOX 5 Recommendations for care post-abortion Contraception Women may start hormonal contraception at the time of surgical abortion, or as early as the time of administration of the first pill of a medical abortion regimen. Following medical abortion, an intrauterine device (IUD) may be inserted when it is reasonably certain that the woman is no longer pregnant. (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: very low.) See also: Annex 5, Recommendation 13, page 118. Follow-up There is no medical need for a routine follow-up visit following uncomplicated surgical abortion or medical abortion using mifepristone followed by misoprostol. However, women should be advised that additional services are available to them if needed or desired. (Strength of recommendation: strong. Quality of the evidence based on observational studies and indirect evidence: low.) See also: Annex 5, Recommendation 9, page 117. Incomplete abortion If uterine size at the time of treatment is equivalent to a pregnancy of gestational age 13 weeks or less, either vacuum aspiration or treatment with misoprostol is recommended for women with incomplete abortion. The recommended regimen of misoprostol is a single dose given either sublingually (400 μg) or orally (600 μg). (Strength of recommendation: strong. Quality of evidence based on randomized controlled trials: low.) See also: Annex 5, Recommendation 10, page 117. Safe abortion: technical and policy guidance for health systems 7

18 BOX 6 Recommendations for health systems To the full extent of the law, safe abortion services should be readily available and affordable to all women. This means services should be available at primary-care level, with referral systems in place for all required higher-level care. Actions to strengthen policies and services related to abortion should be based on the health needs and human rights of women and a thorough understanding of the service-delivery system and the broader social, cultural, political and economic context. National standards and guidelines for safe abortion care should be evidence based and periodically updated, and should provide the necessary guidance to achieve equitable access to good-quality care. New policy and programme interventions should reflect evidence-based best practices. Complex service-delivery interventions require local evidence of feasibility and effectiveness through pilot-testing on a small scale prior to investing resources in scaling-up. Training of abortion providers must ensure that they have the competencies to provide good-quality care in accordance with national standards and guidelines. Ensuring good-quality abortion care requires ongoing supervision, quality assurance, monitoring and evaluation. Financing of abortion services should take into account costs to the health system while ensuring that services are affordable and readily available to all women who need them. Costs of adding safe abortion care to existing health services are likely to be low, relative to the costs to the health system of treating complications of unsafe abortion. Successful scaling-up requires systematic planning, management, guidance and support for the process by which pilot interventions are both expanded and institutionalized. It also requires sufficient human and financial resources to support the process. See Chapter 3 for further details. 8 Safe abortion: technical and policy guidance for health systems

19 BOX 7 Recommendations related to regulatory, policy and human rights considerations Laws and policies on abortion should protect women s health and their human rights. Regulatory, policy and programmatic barriers that hinder access to and timely provision of safe abortion care should be removed. An enabling regulatory and policy environment is needed to ensure that every woman who is legally eligible has ready access to safe abortion care. Policies should be geared to respecting, protecting and fulfilling the human rights of women, to achieving positive health outcomes for women, to providing good-quality contraceptive information and services, and to meeting the particular needs of poor women, adolescents, rape survivors and women living with HIV. See Chapter 4 for further details. Safe abortion: technical and policy guidance for health systems 9

20 Process of guideline development Background Safe abortion: technical and policy guidance for health systems was published by the World Health Organization (WHO) in 2003 (2) as the first global guidance for abortion-related care and policy issues. Since that time, the guidance has been translated into French, Russian, Spanish and various non-official United Nations (UN) languages and has been widely used by governments, nongovernmental organizations (NGOs), providers of women s health services, and women s health and human rights advocates. Since publication of the guidance in 2003, a considerable amount of new data have been produced and published, relating to epidemiological, clinical, service delivery, legal and human rights aspects of providing safe abortion care. Therefore, preparation for this revision of the guidance included extensive literature review and updating of recommendations related to service delivery, legal and policy issues, and the conduct of new systematic reviews and updates of outdated systematic reviews to provide the evidence for recommendations related to clinical questions prioritized by an international panel of experts. The substantial revisions in this update reflect changes in methods of abortion and related care, service delivery as it applies to the availability and use of new methods, and application of human rights for policy-making and legislation related to abortion, among other topics. Recommendations in the 2003 guidance for which there was no new evidence remain unchanged. Additionally, in parallel with the revision of the guidance, a companion document entitled Clinical practice handbook for safe abortion care has been developed for providers of abortion services, with additional information on the details of implementing the clinical care recommendations of the guidance document. Methods This document was prepared according to the WHO standards and requirements for guideline development. In summary, this process included: identification of priority questions and outcomes; evidence retrieval, assessment and synthesis; formulation of recommendations; and planning for dissemination, implementation, impact evaluation and updating. The identification of priority questions for recommendations was initiated by professional staff from the WHO Department of Reproductive Health and Research (WHO Secretariat), who drafted a list of questions and outcomes related to provision of safe abortion care in light of new data since the initial publication of the guidance in 2003 (2), as well as in response to solicited feedback from its users. A global panel of international stakeholders, including health-service providers, health programme managers, researchers, methodologists, human rights lawyers, and women s health and human rights advocates, was established to review and prioritize the draft questions and outcomes, which included clinical, technical and programmatic topics. This initial consultation was conducted electronically, and all responses were reviewed by members of the WHO Secretariat. Questions and outcomes rated as critical were included in the scope of this document, for evidence grading using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, and the development of recommendations. The list of final questions considered for GRADE tables and outcomes is presented in Annex 2. Cochrane systematic reviews of randomized clinical trials were the primary source of evidence for the recommendations. Based on the list of priority questions, identified as described above, the relevant Cochrane systematic reviews (3 14) were identified and conducted or updated using their specific, 10 Safe abortion: technical and policy guidance for health systems

21 standard search strategies. Additionally, three systematic reviews were conducted outside of the Cochrane Database of Systematic Reviews and were published in peer-reviewed journals (15 17). The search strategies and the specific criteria for including and excluding trials identified by the search are provided in the corresponding systematic reviews. The available evidence was appraised and graded following the GRADE approach (18 22), reflecting the priority comparisons and outcomes; comparisons and outcomes not relevant to the recommendation were excluded. As a result, evidence profiles (GRADE tables) were prepared (available from WHO_RHR_12.10_eng.pdf) - date accessed 14 February Standardized criteria for grading the evidence using GRADE are presented in Annex 3. For each selected comparison, data for available priority outcomes have been assessed and presented in the evidence profiles (if data for priority outcomes were not available in specific comparisons, they were omitted in the GRADE tables). Based on the evidence profiles, recommendations were drafted by the WHO Secretariat. For Chapter 3 on establishing and strengthening safe abortion services, two issues were identified (indicators of safe abortion and competencies for providing safe abortion) for which recent WHO guidance was already available. Therefore, the steps taken to address the topics in Chapter 3 were to adopt and reference recent WHO guidance, and to conduct an extensive literature review of the issues presented for the existing recommendations from the first edition of the document, while updating the references. For Chapter 4 on legal and policy considerations, WHO contracted the Programme on International Reproductive and Sexual Health Law in the Faculty of Law at the University of Toronto, Toronto, Canada, to assist the revision, including proposing changes to the existing content, based on international and regional human rights treaty provisions and the work of international and regional human rights bodies. Staff at the programme also produced a series of research briefs providing human rights and legal research and analysis on selected issues of particular concern (for example, elaboration of the health indication for safe abortion, conscientious objection, and legal and regulatory barriers). In order to review the draft recommendations and the supporting evidence, a technical consultation was organized at WHO headquarters in Geneva, Switzerland. The members of a guidelines development group a subset of the international panel that participated in the initial online consultation and other experts were invited to participate in this consultation (see Annex 4 for a list of participants and their affiliations). Draft recommendations, revised chapters and supporting documents were shared with the participants before the consultation for their review. Declarations of interest were obtained from the participants in the technical consultation using a standard WHO form prior to their participation in the meeting. These declarations were reviewed by the WHO Secretariat and, when necessary, by the WHO Office of the Legal Counsel before the consultation. Two consultation participants (Dr Laura Castleman and Dr Helena von Hertzen) declared that they were employed by organizations that have or might appear to have commercial conflicts of interest. For recommendations that were directly relevant to their organizations work, they left the room during final recommendation making. No other participants declared any conflicts or potential conflicts of interest. Safe abortion: technical and policy guidance for health systems 11

22 Decision-making during the technical consultation For each recommendation, the participants in the technical consultation discussed the draft text prepared by the WHO Secretariat, with the aim of reaching consensus. Consensus was defined as agreement by the majority of participants, with no one strongly disagreeing. No strong disagreements occurred during the consultation and, therefore, an alternative system, such as voting, was not necessary. In addition to the scientific evidence and its quality, applicability issues, costs and other expert opinions were considered while formulating the final recommendations. The strength of the recommendations was determined through the assessment of each intervention on the basis of: (i) desirable and undesirable effects; (ii) the quality of available evidence; (iii) values and preferences related to interventions in different settings; (iv) the cost of options available to health-care workers in different settings; and (v) the perceived likelihood of changing the recommendation due to further research. In general, a strong recommendation with moderate- or high-quality evidence indicates that further research should not be considered a priority. The full text of the recommendations from the technical consultation is found in Annex 5. Topics not identified as the subject of a new systematic review for which WHO recommendations already existed were presented at the technical consultation, for group discussion. Those recommendations found by the group to be relevant and current were endorsed and adopted. These topics included: indicators of safe abortion; contraceptive use following abortion; and the recommendations surrounding establishing and strengthening abortion services, including competencies for providing abortion care, found in Chapter 3. Document preparation and peer review A preliminary document, containing the draft recommendations, was prepared and made available to the participants in the technical consultation three weeks before the meeting. The draft recommendations were amended during the meeting, based on the discussions. After the meeting, the draft document was revised by the WHO Secretariat. The revised version was sent electronically to all participants, for their approval and comments. Primary reviewers for each chapter were identified based on their fields of expertise. Finally, the whole document was sent for external critical appraisal and peer review. During this process of review, important suggestions were incorporated into the document; however, the WHO Secretariat refrained from making major changes in the scoping (e.g. further expansion of the guidance scoping) or in the recommendations agreed upon during the consultation. Dissemination of the guidance document As with the first edition of the guidance document, dissemination will be undertaken through distribution of the print version, and a series of regional workshops will be organized on applying the WHO Strategic Approach to strengthening sexual and reproductive health policies and programmes (23) to the issue of unsafe abortion. The aim of the workshops will be to develop proposals based on the guidance that can strengthen safe abortion care within sexual and reproductive health programmes. The workshops will include preselected country teams with representatives from ministries/departments of health, including a variety of health-service providers and programme managers, and representatives from NGOs, professional associations and UN organizations. 12 Safe abortion: technical and policy guidance for health systems

23 Assessing the impact of published guidelines is a challenging task. In an attempt to do so, we plan to monitor the number of requests from countries for assistance in implementation of the guidelines, direct follow-up in countries applying the Strategic Approach, and the number of countries that modify their national abortion programme monitoring to reflect the indicators for safe abortion provided in Table 3.2 (page 75) of this document. Additionally, we will continue to monitor the number of downloads of the document, as well as the number of hard copies of the guidance requested and distributed. Updating the guidelines The WHO Secretariat anticipates that these guidelines will be reviewed again four years following their publication, to assess whether revision is necessary, based upon newly available evidence and feedback from users. Safe abortion: technical and policy guidance for health systems 13

24 References 1. Unsafe abortion: global and regional estimates of the incidence of unsafe abortion and associated mortality in 2008, 3rd ed. Geneva, World Health Organization, Safe abortion: technical and policy guidance for health systems. Geneva, World Health Organization, Kulier R et al. Medical methods for first trimester abortion. Cochrane Database of Systematic Reviews, 2004, (1):CD002855, updated Kulier R et al. Surgical methods for first trimester termination of pregnancy. Cochrane Database of Systematic Reviews, 2001, (4):CD Say L et al. Medical versus surgical methods for first trimester termination of pregnancy. Cochrane Database of Systematic Reviews, 2005, (1):CD003037, updated Lohr PA, Hayes JL, Gemzell-Danielsson K. Surgical versus medical methods for second trimester induced abortion. Cochrane Database of Systematic Reviews, 2008, (1):CD Wildschut H et al. Medical methods for mid-trimester termination of pregnancy. Cochrane Database of Systematic Reviews, 2011, (1):CD Kapp N et al. Cervical preparation for first trimester surgical abortion. Cochrane Database of Systematic Reviews, 2010, (2):CD Promsonthi P, Preechapornprasert D, Chanrachakul B. Nitric oxide donors for cervical ripening in firsttrimester surgical abortion. Cochrane Database of Systematic Reviews, 2009, (4):CD Newmann SJ et al. Cervical preparation for second trimester dilation and evacuation. Cochrane Database of Systematic Reviews, 2010, (8):CD Neilson JP et al. Medical treatments for incomplete miscarriage (less than 24 weeks). Cochrane Database of Systematic Reviews, 2010, (1):CD Tunçalp O, Gülmezoglu AM, Souza JP. Surgical procedures for evacuating incomplete miscarriage. Cochrane Database of Systematic Reviews, 2010, (9):CD Mueller M et al. Antibiotic prophylaxis for medical and surgical first trimester induced abortion. Cochrane Database of Systematic Reviews, 2012, 2012, (3):CD Renner RM et al. Pain control in first trimester surgical abortion. Cochrane Database of Systematic Reviews, 2009, (2):CD Kulier R, Kapp N. Comprehensive analysis of the use of pre-procedure ultrasound for first- and secondtrimester abortion. Contraception, 2011, 83: Grossman D, Grindlay K. Alternatives to ultrasound for follow-up after medication abortion: a systematic review. Contraception, 2011, 83(6): Jackson E, Kapp N. Pain control in first-trimester and second-trimester medical termination of pregnancy: a systematic review. Contraception, 2011, 83: Guyatt GH et al. Incorporating considerations of resources use into grading recommendations. British Medical Journal, 2008, 336: Guyatt GH et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. British Medical Journal, 336: Guyatt GH et al. What is quality of evidence and why is it important to clinicians? British Medical Journal, 2008, 336: Guyatt GH et al. Going from evidence to recommendations. British Medical Journal, 2008, 336: Schünemann HJ et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. British Medical Journal, 2008, 336: The WHO Strategic Approach to strengthening sexual and reproductive health policies and programmes. Geneva, World Health Organization, Safe abortion: technical and policy guidance for health systems

25 Safe abortion: technical and policy guidance for health systems 15

26 Chapter 1 Safe 16abortion Safe care: abortion: the public technical health and and policy human guidance rights for rationale health systems Safe abortion care: the public health and human rights rationale

27 Chapter 1 Safe abortion care: the public health and human rights rationale Summary y Each year, 22 million unsafe abortions are estimated to take place. Nearly all unsafe abortions (98%) occur in developing countries. The total number of unsafe abortions has increased from about 20 million in 2003 to 22 million in 2008, although the global rate of unsafe abortion has remained unchanged since y Approximately pregnancy-related deaths are due to complications of unsafe abortion. In addition, 5 million women are estimated to suffer disability as a result of complications due to unsafe abortion. y Impressive gains in contraceptive use have resulted in reducing the number of unintended pregnancies, but have not eliminated the need for access to safe abortion. An estimated 33 million contraceptive users worldwide are expected to experience accidental pregnancy annually while using contraception. Some of the accidental pregnancies are terminated by induced abortions, and some end up as unplanned births. y Whether abortion is legally more restricted or available on request, a woman s likelihood of having an unintended pregnancy and seeking induced abortion is about the same. However, legal restrictions, together with other barriers, mean many women induce abortion themselves or seek abortion from unskilled providers. The legal status of abortion has no effect on a woman s need for an abortion, but it dramatically affects her access to safe abortion. y Where legislation allows abortion under broad indications, the incidence of and complications from unsafe abortion are generally lower than where abortion is legally more restricted. y In almost all countries, the law permits abortion to save the woman s life, and in the majority of countries abortion is allowed to preserve the physical and/or mental health of the woman. Therefore, safe abortion services, as provided by law, need to be available. y Unsafe abortion and associated morbidity and mortality in women are avoidable. Safe abortion services therefore should be available and accessible for all women, to the full extent of the law. 1.1 Background Induced abortion has been documented throughout recorded history (1). In earlier times, abortions were unsafe and exerted a heavy toll on women s lives. Advances in medical practice in general, and the advent of safe and effective technologies and skills to perform induced abortion in particular, could eliminate unsafe abortions and related deaths entirely, providing universal access to these services is available. Yet, an estimated 22 million abortions continue to be unsafe each year, resulting in the death of an estimated women (2). Safe abortion care: the public health and human rights rationale Safe abortion: technical and policy guidance for health systems 17

28 Unsafe abortion is defined by the World Health Organization (WHO) as a procedure for terminating an unintended pregnancy, carried out either by persons lacking the necessary skills or in an environment that does not conform to minimal medical standards, or both. In nearly all developed countries (as classified by the United Nations Population Division) safe abortions are legally available upon request or under broad social and economic grounds, and services are generally accessible to most women. With the exception of a few countries, access to safe abortion in developing countries is limited to a restricted number of narrow conditions (3). In countries where abortion is legally highly restricted, unequal access to safe abortion may result. In such contexts, abortions that meet safety requirements can become the privilege of the rich, while poor women have little choice but to resort to unsafe providers, which may cause disability and death (4). This chapter provides an overview of the health, demographic, legal and policy context of induced abortion with updated data since the publication of the document Safe abortion: technical and policy guidance for health systems by WHO in 2003 (5). 1.2 Public health and human rights A consensus on the public health impact of unsafe abortion has existed for a long time. As early as 1967, the World Health Assembly identified unsafe abortion as a serious public health problem in many countries (6). WHO s Reproductive Health Strategy to accelerate progress towards the attainment of international development goals and targets, adopted by the World Health Assembly in 2004, noted: As a preventable cause of maternal mortality and morbidity, unsafe abortion must be dealt with as part of the Millennium Development Goal on improving maternal health and other international development goals and targets (7). The number of declarations and resolutions signed by countries over the past two decades (see for example, references 8 11) indicates a growing consensus that unsafe abortion is an important cause of maternal death that can, and should, be prevented through the promotion of sexuality education, family planning, safe abortion services to the full extent of the law, and post-abortion care in all cases. The consensus also exists that post-abortion care should always be provided, and that expanding access to modern contraception is critical to the prevention of unplanned pregnancy and unsafe abortion. Thus, the public health rationale for preventing unsafe abortion is clear and unambiguous. Discussions that grew out of the 1968 International Conference on Human Rights in Tehran, Islamic Republic of Iran, culminated in the new concept of reproductive rights, which was subsequently defined and accepted at the 1994 International Conference on Population and Development (ICPD) in Cairo, Egypt (8). Eliminating unsafe abortion is one of the key components of the WHO Global reproductive health strategy (12). The strategy is grounded in international human rights treaties and global consensus declarations that call for the respect, protection and fulfilment of human rights, including the right of all persons to the highest attainable standard of health; the basic right of all couples and individuals to decide freely and responsibly the number, spacing and timing of their children and to have the information and means to do so; the right of women to have control over, and decide freely and responsibly on, matters related to their sexuality, including sexual and reproductive health free of coercion, discrimination and violence; the right of men and women to choose 18 Safe abortion: technical and policy guidance for health systems Safe abortion care: the public health and human rights rationale